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Completed

NCT Number: NCT06545916

Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder

The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.

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Key information

Conditions

Alcohol Use Disorder Alcohol Drinking Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bio Terra Med SRL, Bucharest, Romania

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria include:

  • Male and female age ≥18 years.
  • Diagnosis of moderate or severe alcohol use disorder.
  • Currently seeking treatment for alcohol use disorder.
  • Has 4 or more heavy drinking days (HDD) in each of the 4 weeks prior to baseline visit.

Key Exclusion Criteria include:

  • Subjects that meet current DSM-5 criteria for moderate or severe substance use disorder other than alcohol and nicotine.

Other protocol-specific inclusion and exclusion criteria may apply.

Treatment and study plan

Sunobinop

Drug

1 tablet taken orally at bedtime

Other names: V117957

Placebo to match sunobinop

Drug

1 tablet taken orally at bedtime

Primary outcomes

  1. Percent heavy drinking days (HDD)

    Time frame: Day 57

Secondary outcomes

  1. Number of standard unit drinks

    Time frame: Day 57

  2. Percent of drinking days (PDD)

    Time frame: Day 57

Sponsors and collaborators

Lead sponsor

Knoa Pharma LLC

Industry

Collaborators

  • Imbrium Therapeutics

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Consumption in Subjects Diagnosed With Moderate to Severe Alcohol Use Disorder and Seeking Treatment

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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